DepressionBAFHNCT01587326
The Effects of Escitalopram on Cytokines
A study testing Escitalopram in people with Depression, run by Beitou Armed Forces Hospital, Taipei, Taiwan at 1 site in Taiwan.
Trial summary
The association of cytokines with escitalopram has not been investigated in patients with major depressive disorder (MDD). Hence, the investigators will examine this association. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Escitalopram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2012to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-IV-defined Major depressive disorder, single episode
- Age 20-65
- Drug-naive
- Hamilton Depression Rating Scale exceeding 14 scores
Who cannot join
- Major medical disorders
- Substance use
- Pregnant
- Allergy to escitalopram
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Beitou Armed Forces Hospital
Taipei
Chih-Sung Liang, M.D., +886-2-8959808, lcsyfw@gmail.com
About this study
Official title: The Effects of Escitalopram on Cytokines in Depressive Patients
The association of cytokines with escitalopram has not been investigated in patients with major depressive disorder (MDD). Hence, the investigators will examine this association.
Read the detailed description
In addition to serotonin, inflammatory process has been suggested in the development of major depressive disorder (MDD) and in its associated treatment. Escitalopram is an antidepressant that has been widely used in patients with MDD because of the promising results. The association of cytokines with escitalopram has not been investigated in patients with MDD. Hence, the investigators will examine this association.
- Conditions
- Depression
- Being tested
- Escitalopram
- Keywords
- cytokine, depression, escitalopram
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called Lexapro
escitalopram 10 mg/d to 20 mg/d
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram | Experimental | Escitalopram 10 mg/d to 20 mg/d Receives: Drug: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes in cytokines
Hamilton Depression Rating Scale, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17A, G-CSF, GM-CSF, IFN-γ, MCP-1, MIP-1β, TNF-α
Measured: Week 0, Week 4
Secondary outcomes (1)
The changes in Hamilton Depression Rating Scale
Hamilton Depression Rating Scale, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17A, G-CSF, GM-CSF, IFN-γ, MCP-1, MIP-1β, TNF-α
Measured: week 0, week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beitou Armed Forces Hospital, Taipei, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Peishen Ho, M.D., Study chair, Beitou Armed Forces Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587326
- Sponsor's protocol ID
- BAFH-101-05
- Other IDs
- BAFH
- Acronym
- BAFH
- Status last verified
- May 2012
- First submitted
- 26 Apr 2012
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Escitalopram on Cytokines in Depressive Patients
- ClinicalTrials.gov ID
- NCT01587326
- Acronym / sponsor ID
- BAFH / BAFH-101-05
- Conditions
- Depression
- Keywords
- cytokine, depression, escitalopram
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Beitou Armed Forces Hospital, Taipei, TaiwanOther government
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 30 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The association of cytokines with escitalopram has not been investigated in patients with major depressive disorder (MDD). Hence, the investigators will examine this association.
Detailed description
In addition to serotonin, inflammatory process has been suggested in the development of major depressive disorder (MDD) and in its associated treatment. Escitalopram is an antidepressant that has been widely used in patients with MDD because of the promising results. The association of cytokines with escitalopram has not been investigated in patients with MDD. Hence, the investigators will examine this association.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Escitalopram | Experimental | Drug: EscitalopramEscitalopram 10 mg/d to 20 mg/d |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- DSM-IV-defined Major depressive disorder, single episode
- Age 20-65
- Drug-naive
- Hamilton Depression Rating Scale exceeding 14 scores
Key exclusion criteria (4 listed)
- Major medical disorders
- Substance use
- Pregnant
- Allergy to escitalopram
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EscitalopramAlso: Lexaproescitalopram 10 mg/d to 20 mg/d | Drug | Escitalopram |
Primary outcome
The changes in cytokines
Time frame: Week 0, Week 4
Hamilton Depression Rating Scale, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17A, G-CSF, GM-CSF, IFN-γ, MCP-1, MIP-1β, TNF-α
1 secondary outcome
The changes in Hamilton Depression Rating Scale
Time frame: week 0, week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peishen Ho, M.D. study chair
Beitou Armed Forces Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Escitalopram in people with Depression, run by Beitou Armed Forces Hospital, Taipei, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pei-Shen Ho, M.D. (+886-2-28959808, luke_and_tina@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes in cytokines (time frame: Week 0, Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2012.